Sher and Bewley Quoted in Pink Sheet on OIG’s Review of FDA Approval Process for Aduhelm

Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate
– Pink Sheet

Manatt Health Partners Rachel Sher and Brian Bewley were quoted in Pink Sheet on the Office of Inspector General’s (OIG) review of the U.S. Food and Drug Administration’s (FDA) accelerated approval of Aduhelm, an Alzheimer’s drug developed by Biogen, Inc. 

The article explained that as part of its review process, the OIG will likely request documents connected to Biogen’s evaluation, including communication between the FDA and Biogen with information on any events where FDA personnel might have appeared or interacted with Biogen employees or coauthored any papers.  

Sher noted that other process questions may be addressed by looking at science-centric documents like interactions between the FDA and Biogen about clinical trial protocol development, including aspects like enrollment criteria. Bewley added that the OIG has incredibly broad authority to request all relevant materials, including drafts of documents, emails, and any written communication between Biogen and the FDA, although Sher said she doesn’t expect the FDA will give the OIG a hard time in its request. Agency staff and senior leadership are “probably going to welcome the opportunity to speak with OIG because 

they don’t necessarily want the OIG to interpret written materials in a vacuum without the FDA having the  opportunity to provide additional context,” Bewley concluded. 

Pink Sheet subscribers can read the full article here
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